The rise of research on psychedelic substances is closely linked to the increase in mental illness worldwide, especially cases of refractory (resistant) depression. According to the World Health Organization (WHO), around 322 million people suffer from depression worldwide.
In Latin America, Brazilians also have a lot to worry about: they are the record holders for the disease on the continent, affecting approximately 11 million people, according to WHO data. However, when we talk about treating depression with psychedelics, we refer to cases where conventional treatments don't work.
In this regard, in 2019, the Federal University of Minas Gerais (UFMG) presented a multicenter observational study Where did I estimate that of 30% to 40% of patients with depression in Latin America did not respond to medications, thus making them more susceptible to suicide. The study was conducted with 1,475 participants from countries such as Brazil, Argentina, Colombia, and Mexico. In this regard, the data on Brazilians stand out: at least 40.4% of patients they present cases considered to be resistant depression.
In addition, demand does not seem to be inclined to decrease. The WHO estimates that by 2030, depression will be the most common disease in the world, surpassing heart disease and cancers. However, psychedelics have a more comprehensive potential, and current research also seeks solutions to treat post-traumatic stress disorder (PTSD), Narcolepsy, Syndrome of panic and opioid addiction (caused by the use of substances such as morphine, codeine, heroin, hydrocodone, and others).
Faced with this scenario, are the prospects for the psychedelic market. According to the Psychedelic Drugs Global Market Report, made by The Business Research Company, the segment is expected to grow by around 15.1% in 2024 — rising from the level of 4.88 billion dollars in 2023, to move 5.62 billion dollars this year. For the following years, the estimate is for rapid growth and up to 2028 is expected to generate 10.2 billion dollars in the industry.
The factors for such optimism? Also according to the report, the regulatory landscape is advancing, so is mental health awareness, and there is greater acceptance of this type of treatment, both by patients and by doctors.
Relevant market movements
To arrive at the current scenario, some events were essential. There was a historic moment around the 1960s, when several studies were being carried out with psychedelic drugs, until the counterculture movement in the 1970s prompted the closure of these studies and the prohibition of recreational use.
Around the 2000s, research on psychedelics slowly resumed, until they arrive in 2020, when they gain a pulse again. Since then, we can highlight as main events:
1. Legalization of psilocybin for therapeutic use in the state of Oregon, USA
In November 2020, Oregon became the first U.S. state to legalize psilocybin for therapeutic use in adults. The measure took effect in December 2021 and allows adults 21 and older to access psilocybin at clinics licensed to treat a variety of conditions, including depression, anxiety, and PTSD.
2. FDA grants psilocybin “breakthrough therapy” status for PTSD
In November 2021, the U.S. Food and Drug Administration (FDA) granted psilocybin “breakthrough therapy” status for the treatment of PTSD. This designation streamlines the process of developing and reviewing new drugs, and indicates that the FDA recognizes psilocybin's potential to treat PTSD.
3. Study shows psilocybin's potential to treat depression
Published in 2022 in the magazine Nature Medicine, the study showed that psilocybin helped increase brain connections in patients with depression.
4. Australia is the first country to approve the use of psychedelics for mental health treatment
In mid-2023, Australia became the first country to release the use of substances such as psilocybin and MDMA (also known as ecstasy) for the treatment of medication-resistant depression and post-traumatic stress disorder, respectively.
What is happening in Brazil today
Despite regulatory advances in other countries, only a few substances are allowed in Brazil. Among them, is ketamine (may also be called ketamine), a substance that was initially an anesthetic used in surgery, but was approved by Anvisa in 2020 to treat resistant depression, using an intranasal drug. However, its use is restricted to the hospital environment, as it requires the supervision of a professional.
The famous psilocybin, originating from “magic mushrooms”, is prohibited - except when in research contexts. In these cases, the National Health Surveillance Agency (Anvisa) authorizes previously accredited centers that offer the patient an experienced medical team for follow-up.
In the meantime, the Ibogaine it is one of the substances that remain in a 'neutral' legal zone. In other words, the substance is not legal in Brazil, but Anvisa allows it to be imported for treatment against chemical dependency and depression. In general, research authorization for ibogaine is restricted to animal research, but in June 2023, the School of Medicine of Ribeirão Preto, of the University of São Paulo (FMRP-USP), initiated Search for volunteers to study the substance. Other substances such as LSD, ayahuasca, DMT, and mescaline work under the same criteria.
Devised under all this scenario is the Psychedelic Science Scirama, the first and only Brazilian startup focusing on psychedelic treatments and Beneva Clinic, which treats mental disorders and chemical dependency using psychedelics. But in such a restricted scenario, how do these initiatives manage to work?
How does psychedelic treatment work?
One of the key elements for researching the psychedelic niche is the concept of”Set and setting”. “In the area of psychedelic medicine, the 'set' is how the patient is prepared to undergo psychedelic therapy, so everything that needs to be structured in the patient for him to live that process properly. The 'setting', on the other hand, is the space, the environment and the stimuli that it will have during the process,” explains Clarice Pires, CEO of the startup Scirama Psychedelic Science.
She continues, exemplifying the issue: “When we are going to undergo therapy in which the patient will have access to this molecule in therapeutic doses, we think about where he needs to be, what security format he must live in, if he is going to be in a room with a reclining chair, if he is going to use bandages, receive musical and audiovisual stimulation, lights and the like”. All of this is always accompanied by previously trained medical teams ready for the most diverse scenarios.
These elements have become common protocols since the approval of the therapeutic use of psilocybin in the state of Oregon, in the USA, and serve to minimize possible side effects (such as nausea, vomiting, tremors, tachycardia, or psychosis).
The issue of regulation
In Brazil, official regulation still depends on advances in clinical research. However, the main expectation revolves around international health regulators, which must register MDMA as a drug by August of this year. Among other wishes, new studies should support the regulation of psilocybin and DMT in the future.
However, the use of ketamine for the treatment of refractory depression or other disorders is possible through the “off-label” feature, that is, if the doctor considers it positive for the patient - especially when it comes to severe depression, with suicidal ideation - the prescription is allowed.
“Ketamine itself has an anesthetic indication, but a doctor can make a decision and say I will use it for depression in my patient because my patient is severely depressed. I need to prevent that patient from dying, so I prescribe it off-label. In addition, there are already structured clinics in Brazil that prescribe ketamine infusions for the treatment of depression as part of a medical protocol,” explains Clarice.
In this sense, Clínica Beneva is one of the pioneers in Latin America and has three types of treatments in clinics, namely: two using the active ingredient Ketamine for depression - either intravenously or with the application of the drug Spravato, registered by Anvisa - and another
with pharmaceutical-grade ibogaine. Performed in a hospital setting, the treatment focuses on the recovery of patients with chemical dependencies.
Perspectives for the future
In general, treatment with psychedelic substances generated a certain amount of public distrust. However, with the advancement of research and protocols, the alternative seems to be attractive enough for patients to join on their own.
“When we started the project, we were advised by communication consultants to avoid the word “psychedelic”. But if we had avoided the term, we wouldn't be telling the patients exactly what we came to bring. Our protocols aren't just a novelty in psychiatry, we're not a new 'Prozac'. We came to bring a true paradigm shift to psychiatry and the word psychedelic helps us to say that. Communicating this isn't easy. Of course, this required educating our patients, close psychologists and referring doctors,” says Marco Algorta, CEO of Clínica Beneva.
Algorta continues, stating that “today, many patients come on their own initiative, tired of years of poor results with classic treatments, many are encouraged by relatives or friends and, this is the number that grows the most, most are recommended by doctors who choose to have their patients treated with our protocols. The growing interest of the medical profession in our treatments is evident”.
Finally, Marco is optimistic about the coming years. “With the growth that we are experiencing in our clinics, we will certainly open new units before the end of the year. In the coming months, not only will we be attending with new protocols and in new units, but also with new substances and possible unprecedented medical treatments. The future has arrived”, concludes the CEO.
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